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Executive Director, Clinical Development - Ireland  

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Posted on : 20 February 2017

Project Description

 
About Us:
  • Our company is seeking a clinical development physician to join the Life Cycle Management Clinical Development team in the Sleep Therapeutic Area.  
  • You will be responsible for  generating global (US and Ex US) clinical development plans and protocols to support new indications, medical monitoring of trials, the oversight and interpretation of clinical trials data, clinical interactions with investigators and multidisciplinary groups across the company including R&D, commercial, regulatory and business development

Job Responsibilities:
  • Serve as clinical  leader on trials that have the potential to expand the indications for  molecules currently in development as well as for commercialized products.
  • Develop and implement strategic clinical plans in alignment with LCM goals for the Sleep TA .
  • Identify and interact with opinion leaders to integrate current clinical  practice and guidelines into global clinical development plans including  relevant industry developments
  • Work with project team members, regulatory affairs and senior management to integrate competitive intelligence and regulatory strategy with the clinical strategic plan.
  • Develop phase II -IV clinical protocols and work closely with other functional areas within the R&D Departments (regulatory, clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programs
  • Provide clinical input to Statistical Analysis Plan and assume responsibility for the clinical review and interpretation of the clinical trial data.
  • Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, etc) and review sections from other functional areas
  • Develop strategy for and lead clinical advisory board meetings to obtain strategic input into clinical development programs
  • Lead preparation of clinical portions of all relevant regulatory filings (IND, NDA, etc) and review sections from other functional areas
  • Develop strategy for and lead clinical advisory board meetings to obtain strategic input into clinical program development
  • Serve as clinical (and medical) resource for clinical issues raised by internal and external collaborators, investigators, consultants and business development and investor contacts
  • Serve as lead clinical (and or medical) representative with regulatory agencies
  • Provide strategic input on new product concepts, long-range strategic plans and licensing opportunities
  • Provide leadership in collaborations with strategic partners.
  • Supervise and be accountable for the generation of and management of messaging in clinical program and regulatory submissions
  • Accountable for success and implementation of the clinical development strategy
  • Represent the company at scientific, industry, regulatory, advocacy and financial community meetings and presentations, as well as other public relations opportunities.
  • Monitor clinical trials for safety
  • Work in conjunction with Drug Safety and Pharmacovigilance to insure timely reporting of safety signals to regulatory authorities  
  • This person will provide leadership and lead and manage Clinical Scientists as the team grows.


ESSENTIAL QUALIFICATIONS
  • MD, DO degree – psychiatrist, neurologist, sleep specialist,  preferred but other physicians will be  considered, particularly those with expertise in clinical development in neurology, sleep or psychiatry; U.S. Board Certification/Eligibility preferred
  • 10 years of clinical development  experience.   
  • Demonstrated scientific and therapeutic expertise
  • Excellent written and verbal communications skills and  ability to work in a collaborative team environment


PREFERRED REQUIREMENTS:
  • Experience with IND and NDA submissions preferred
  • Experience interacting with regulators and business partners preferred
  • Collaborative and flexible in personal interactions at all levels of the company
  • Ability to work proactively and effectively, with exceptional creative problem solving skills
  • Proven strategic planning and communication skills across multiple disciplines
  • Demonstrated ability to work with senior management and  provide input toward the setting and execution  of corporate and departmental objective.


EQUAL OPPORTUNITY:
Our company is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.